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Ocular's (OCUL) sNDA for Dextenza Gets FDA Acceptance, Shares Up

Ocular Therapeutix, Inc. OCUL announced that it has submitted a supplemental new drug application (sNDA) to the FDA for expanding the label of its lead marketed drug Dextenza (dexamethasone ophthalmic insert). The company is seeking an approval of Dextenza – 0.4 mg for intracanalicular use, for the treatment of ocular itching associated with allergic conjunctivitis.

The sNDA has been accepted by the FDA and a decision from the regulatory body is expected in October 2021.

Shares of Ocular were up 5.3% following the announcement of the news on Tuesday. In fact, the stock has skyrocketed 466.3% so far this year compared to the industry’s increase of 2.7%.


Per the press release, four vehicle-controlled studies evaluated the efficacy of Dextenza for treating ocular itching. Data from the same showed that Dextenza was found to be superior versus placebo vehicle for addressing ocular itching due to allergic conjunctivitis. Dextenza also demonstrated a favorable safety profile and was generally well-tolerated for the given indication. Moreover, treatment with Dextenza consistently resulted in lower ocular itching compared to placebo vehicle in all the studies.

Per the company, an estimated 10 million people look for medical attention for inflammatory response associated with allergic conjunctivitis in the United States. Hence, if approved for the given indication, Dextenza can serve a market with significant need and potential.

Please note that Dextenza is already approved for the treatment of ocular pain and ocular inflammation post ophthalmic surgery. The drug generated sales worth $8.9 million in the first nine months of 2020. A potential label expansion would further boost the drug sales and drive growth for the company.

Apart from Dextenza, Ocular markets ReSure Sealant, a hydrogel ophthalmic wound sealant approved by the FDA to seal corneal incisions following cataract surgery.

We note that Ocular’s pipeline includes OTX-TIC, an intracameral travoprost implant is being developed for the treatment of patients with primary open-angle glaucoma or ocular hypertension. A phase II study on OTX-TIC for the given indication is expected to begin in mid-2021. Other candidates including OTX-TKI are being developed for the potential treatment of wet age-related macular degeneration (wet AMD) and OTX-CSI which is being developed for the chronic treatment of dry eye disease.

However, competition is stiff in the ophthalmology market with the likes of Aerie Pharmaceuticals AERI and Regeneron Pharmaceuticals REGN in the fray.

Zacks Rank & Key Pick

Ocular currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Ironwood Pharmaceuticals, Inc. IRWD which carries a Zack Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ironwood’s earnings estimates have moved 30.7% and 23.6% north for 2020 and 2021, respectively, over the past 60 days.

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Ironwood Pharmaceuticals, Inc. (IRWD): Free Stock Analysis Report
 
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